Food and Drug Administration/Federal Trade Commission Workshop on a Competitive Marketplace for Biosimilars; Public Workshop; Request for Comments, 6203-6205 [2020-02101]
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
products to various audiences (e.g.,
patients, healthcare providers)?
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02100 Filed 2–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6050]
Food and Drug Administration/Federal
Trade Commission Workshop on a
Competitive Marketplace for
Biosimilars; Public Workshop;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of workshop; request for
comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we), in collaboration with the Federal
Trade Commission (FTC), is announcing
a public workshop on March 9, 2020,
‘‘FDA/FTC Workshop on a Competitive
Marketplace for Biosimilars.’’ The
purpose of the public workshop is to
discuss FDA and FTC’s collaborative
efforts to support appropriate adoption
of biosimilars, discourage false or
misleading communications about
biosimilars, and deter anticompetitive
behaviors in the biologic product
marketplace.
DATES: The public workshop will be
held on March 9, 2020, from 9 a.m. to
5 p.m. Persons seeking to speak at the
public workshop must register by
February 24, 2020. Persons seeking to
attend but not speak at the public
workshop must register by March 4,
2020. Section III provides attendance
and registration information. Electronic
or written comments will be accepted
until April 9, 2020.
ADDRESSES: The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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1503A), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Working
atFDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before April 9, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end
April 9, 2020. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
PO 00000
Frm 00063
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6203
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–6050 for ‘‘FDA/FTC Workshop
on a Competitive Marketplace for
Biosimilars.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments and will
share it with FTC. The second copy,
which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
Hampshire Ave., Bldg. 75, Rm. 6522,
Silver Spring, MD 20993–0002, 301–
796–1042, email: sandra.benton@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA, in collaboration with FTC, is
announcing the following public
workshop entitled ‘‘FDA/FTC Workshop
on a Competitive Marketplace for
Biosimilars.’’ The purpose of the public
workshop is to discuss FDA and FTC’s
collaborative efforts to support
appropriate adoption of biosimilars,
discourage false or misleading
communications about biosimilars, and
deter anticompetitive behaviors in the
biologic product marketplace.
FDA, an agency within the U.S.
Department of Health and Human
Services, protects the public health by
assuring the safety, effectiveness, and
security of human and veterinary drugs,
vaccines, and other biological products
for human use, and medical devices.
The Agency is also responsible for the
safety and security of our nation’s food
supply, cosmetics, dietary supplements,
and products that emit electronic
radiation, and for regulating tobacco
products. Congress has given FDA, as
part of the Agency’s mission to promote
and protect the public health,
responsibility for implementing laws
intended to strike a balance between
encouraging and rewarding innovation
in drug and biological product
development and facilitating robust and
timely market competition for drugs and
biological products.
FDA regulates biological products
under the Public Health Service Act
(PHS Act) (see 42 U.S.C. 262) and the
Food, Drug, and Cosmetic Act (21 U.S.C.
355). This includes review and approval
of biosimilar and interchangeable
products pursuant to an abbreviated
licensure pathway added to the PHS Act
in the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act),1
which allows an applicant seeking
licensure of a proposed biosimilar or
interchangeable product to leverage
FDA’s previous determination of safety
and effectiveness for a reference product
licensed under section 351(a) of the PHS
Act provided the sponsor can
demonstrate that the biosimilar or
interchangeable product meets the
statutory standards for approval. The
BPCI Act was enacted with the intent to
balance innovation and consumer
1 Sections 7001 through 7003 of the Patient
Protection and Affordable Care Act (ACA) (Pub. L.
111–148). See also Biosimilars Action Plan, https://
www.fda.gov/media/114574/download.
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interests.2 FDA has and will continue to
play a critical role in facilitating
increased access to biosimilars, by
supporting robust and timely
competition through, among other
things, the efficient review of
applications for biosimilar and
interchangeable products, which in turn
may help enhance patient access and
reduce cost burdens on patients and our
healthcare system, in addition to
helping to ensure the United States
remains a driving force in medical
innovation. Part of that role includes
helping to ensure communication of
truthful, nonmisleading, and balanced
information about biological products,
through FDA’s oversight of prescription
drug labeling and advertisements by
drug manufacturers, packers and
distributors and those acting on their
behalf, and through FDA’s own
communications. This workshop will
help to advance these important FDA
priorities.
FTC is an independent agency
charged by Congress with protecting the
interests of consumers by enforcing
competition and consumer protection
laws. (See Federal Trade Commission
Act, 15 U.S.C. 41–58.) It exercises
primary responsibility for civil antitrust
enforcement in the pharmaceutical
industry. (For a summary of FTC’s
antitrust actions in the pharmaceutical
industry, see https://www.ftc.gov/
system/files/attachments/competitionpolicy-guidance/overview_pharma_
june_2019.pdf.) FTC also protects
consumers by enforcing laws and rules
that promote truth in advertising and
fair business practices. FTC has
substantial experience evaluating the
generic drug and biosimilar
marketplaces.
FTC vigorously promotes competition
in the healthcare industry through
enforcement, study, and advocacy.
Competition in healthcare markets
benefits consumers by helping to: (1)
Control costs and prices; (2) improve
quality of care; (3) promote innovative
products, services, and delivery models;
and (4) expand access to healthcare
goods and services. One of the FTC’s
long-standing core missions is to ensure
advertising is truthful and not
misleading. This allows consumers to
make well-informed decisions about
how best to use their resources and
promotes the efficient functioning of
market forces by encouraging the
dissemination of accurate information.
As addressed below, this proposed
workshop is consistent with these FTC
priorities.
2 Id.,
PO 00000
section 7001(b) of the ACA.
Frm 00064
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As the marketplace of biological
products continues to expand and
evolve, FDA and FTC expect an increase
in promotional activities involving
reference products and biosimilar and
interchangeable products. FDA, in
collaboration with FTC, supports and
encourages competitive markets for
biological products. Supporting a
competitive marketplace for biological
products including biosimilar and
interchangeable products, is essential
for patient access to medicines and
reducing healthcare costs. Biological
products play a critical role in the
treatment of many serious illnesses,
including rare genetic disorders,
autoimmune diseases, and cancer. For
many of these conditions, there are no
treatment alternatives other than
biological products.
Both FDA and FTC have serious
concerns about false or misleading
communications regarding reference
products and biosimilar or
interchangeable products, and the
potential negative effects of such
communications on public health and
competition. False or misleading
comparisons of reference products and
biosimilar or interchangeable products
may constitute unfair or deceptive
practices that undermine confidence in
biosimilar and interchangeable
products. Both agencies want to ensure
that healthcare professionals and
patients receive truthful and
nonmisleading information about
biological products.
This public workshop is a component
of FDA’s broader effort to facilitate the
growth of a competitive market for
biological products. In July 2018, FDA
issued its Biosimilars Action Plan (see
https://www.fda.gov/media/114574/
download), which focuses on four areas
of FDA activities: (1) Improving the
efficiency of the biosimilar and
interchangeable product development
and approval process; (2) maximizing
scientific and regulatory clarity for the
biosimilar product development
community; (3) developing effective
communications to improve
understanding of biosimilars among
patients, clinicians, and payors; and (4)
supporting market competition by
reducing gaming of FDA requirements
or other attempts to unfairly delay
competition. This joint FDA and FTC
workshop furthers the activities set forth
in the Biosimilars Action Plan.
II. Topics for Discussion at the Public
Workshop
FDA and FTC are holding this public
workshop to engage with stakeholders
about certain aspects of a competitive
market for biological products,
E:\FR\FM\04FEN1.SGM
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Federal Register / Vol. 85, No. 23 / Tuesday, February 4, 2020 / Notices
including biosimilars and
interchangeable products, and to
discuss the important impact these
products have on public health. This
includes:
• U.S. Biosimilar Markets and FDA
Approval Process;
• Enforcement Activities by FDA and
FTC;
• The Benefits of Competition; and
• Improving Stakeholder
Engagement: Education and Access.
FDA and FTC also encourage
comments from stakeholders and the
public relating to steps FDA and FTC
can take to facilitate a competitive
market for biological products.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Participating in the Public
Workshop
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Attendance will be free and on
a first-come, first-served basis. An
agenda for the workshop and any other
background materials will be made
available 5 days before the workshop at
https://www.fda.gov/drugs/news-eventshuman-drugs/public-workshop-fdaftcworkshop-competitive-marketplacebiosimilars-03092020-03092020. If you
need special accommodations because
of a disability, please contact Sandra
Benton (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the
workshop.
Registration and Requests for Open
Public Workshop Speaker Slots. For
those interested in participating as an
Open Public Workshop speaker, please
register at https://www.eventbrite.com/
e/86931096249 as ‘‘In-person Open
Public Workshop presenter.’’ Open
Public Workshop registrations are due
by February 24, 2020; however, if time
is available, you may sign up as an
Open Public Workshop speaker the day
of the meeting. Time and space are
limited and available on a first-come,
first-served basis. Open Public
Workshop speakers may be assigned no
more than 5 minutes for their
presentation and will deliver oral
testimony only (no accompanying slide
deck).
We will do our best to accommodate
requests to make public comments.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations and request time for a
joint presentation. All requests to make
oral presentations must be received by
February 24, 2020. No commercial or
promotional material will be permitted
to be presented or distributed at the
public workshop.
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In-Person Attendance: For those who
would like to attend in person, but who
are not participating in the Open Public
Workshop, please register at https://
www.eventbrite.com/e/86931096249 as
‘‘In-person attendee—no participation.’’
You may choose not to register;
however, seating is limited, and space
will be available on a first-come, firstserved basis.
Persons attending FDA’s workshops
are advised that FDA is not responsible
for providing access to electrical outlets.
Streaming Webcast of the Public
Workshop: For those unable to attend in
person, FDA will provide a live webcast
of the workshop. To join the workshop
via the webcast, please go to https://
www.fda.gov/drugs/news-eventshuman-drugs/public-workshop-fdaftcworkshop-competitive-marketplacebiosimilars-03092020-03092020 for the
webcast address. Please register at
https://www.eventbrite.com/e/
86931096249 as ‘‘online (webcast
only).’’
Media: Please register at https://
www.eventbrite.com/e/86931096249 as
‘‘Media’’ by March 4, 2020.
Transcripts: Please be advised that
when a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES).
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02101 Filed 2–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the Board of Scientific
Counselors for Basic Sciences National
Cancer Institute.
The meetings will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
Fmt 4703
Sfmt 4703
Name of Committee: Board of Scientific
Counselors for Basic Sciences; National
Cancer Institute.
Date: March 9, 2020.
Time: 9:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, Porter
Neuroscience Research Center, 35 Convent
Drive, Building 35A, Bethesda, MD 20892.
Contact Person: Mehrdad M. Tondravi,
Ph.D., Chief Institute Review Office, NCI,
National Institutes of Health, 9609 Medical
Center Drive, ROOM 2W–464 MSC 9711,
Rockville, MD 20852, 240–276–5664,
tondravim@mail.nih.gov.
Name of Committee: Board of Scientific
Counselors for Clinical Sciences and
Epidemiology; National Cancer Institute.
Date: March 10, 2020.
Time: 9:00 a.m. to 2:30 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, Porter
Neuroscience Research Center, 35 Convent
Drive, Building 35A, Bethesda, MD 20892.
Contact Person: Brian E. Wojcik, Ph.D.,
Institute Review Office, Office of The
Director, National Cancer Institute, 6116
Executive Blvd., Room 2201, Bethesda, MD
20892, 301–496–7628, wojcikb@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: January 29, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
National Cancer Institute; Notice of
Closed Meetings
Frm 00065
constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2020–02068 Filed 2–3–20; 8:45 am]
National Institutes of Health
PO 00000
6205
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
E:\FR\FM\04FEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6203-6205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02101]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-6050]
Food and Drug Administration/Federal Trade Commission Workshop on
a Competitive Marketplace for Biosimilars; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in
collaboration with the Federal Trade Commission (FTC), is announcing a
public workshop on March 9, 2020, ``FDA/FTC Workshop on a Competitive
Marketplace for Biosimilars.'' The purpose of the public workshop is to
discuss FDA and FTC's collaborative efforts to support appropriate
adoption of biosimilars, discourage false or misleading communications
about biosimilars, and deter anticompetitive behaviors in the biologic
product marketplace.
DATES: The public workshop will be held on March 9, 2020, from 9 a.m.
to 5 p.m. Persons seeking to speak at the public workshop must register
by February 24, 2020. Persons seeking to attend but not speak at the
public workshop must register by March 4, 2020. Section III provides
attendance and registration information. Electronic or written comments
will be accepted until April 9, 2020.
ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 9, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end April 9, 2020. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-N-6050 for ``FDA/FTC Workshop on a Competitive Marketplace for
Biosimilars.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments and will share it with FTC. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 6204]]
Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301-
796-1042, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA, in collaboration with FTC, is announcing the following public
workshop entitled ``FDA/FTC Workshop on a Competitive Marketplace for
Biosimilars.'' The purpose of the public workshop is to discuss FDA and
FTC's collaborative efforts to support appropriate adoption of
biosimilars, discourage false or misleading communications about
biosimilars, and deter anticompetitive behaviors in the biologic
product marketplace.
FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines,
and other biological products for human use, and medical devices. The
Agency is also responsible for the safety and security of our nation's
food supply, cosmetics, dietary supplements, and products that emit
electronic radiation, and for regulating tobacco products. Congress has
given FDA, as part of the Agency's mission to promote and protect the
public health, responsibility for implementing laws intended to strike
a balance between encouraging and rewarding innovation in drug and
biological product development and facilitating robust and timely
market competition for drugs and biological products.
FDA regulates biological products under the Public Health Service
Act (PHS Act) (see 42 U.S.C. 262) and the Food, Drug, and Cosmetic Act
(21 U.S.C. 355). This includes review and approval of biosimilar and
interchangeable products pursuant to an abbreviated licensure pathway
added to the PHS Act in the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act),\1\ which allows an applicant seeking licensure
of a proposed biosimilar or interchangeable product to leverage FDA's
previous determination of safety and effectiveness for a reference
product licensed under section 351(a) of the PHS Act provided the
sponsor can demonstrate that the biosimilar or interchangeable product
meets the statutory standards for approval. The BPCI Act was enacted
with the intent to balance innovation and consumer interests.\2\ FDA
has and will continue to play a critical role in facilitating increased
access to biosimilars, by supporting robust and timely competition
through, among other things, the efficient review of applications for
biosimilar and interchangeable products, which in turn may help enhance
patient access and reduce cost burdens on patients and our healthcare
system, in addition to helping to ensure the United States remains a
driving force in medical innovation. Part of that role includes helping
to ensure communication of truthful, nonmisleading, and balanced
information about biological products, through FDA's oversight of
prescription drug labeling and advertisements by drug manufacturers,
packers and distributors and those acting on their behalf, and through
FDA's own communications. This workshop will help to advance these
important FDA priorities.
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\1\ Sections 7001 through 7003 of the Patient Protection and
Affordable Care Act (ACA) (Pub. L. 111-148). See also Biosimilars
Action Plan, https://www.fda.gov/media/114574/download.
\2\ Id., section 7001(b) of the ACA.
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FTC is an independent agency charged by Congress with protecting
the interests of consumers by enforcing competition and consumer
protection laws. (See Federal Trade Commission Act, 15 U.S.C. 41-58.)
It exercises primary responsibility for civil antitrust enforcement in
the pharmaceutical industry. (For a summary of FTC's antitrust actions
in the pharmaceutical industry, see https://www.ftc.gov/system/files/attachments/competition-policy-guidance/overview_pharma_june_2019.pdf.)
FTC also protects consumers by enforcing laws and rules that promote
truth in advertising and fair business practices. FTC has substantial
experience evaluating the generic drug and biosimilar marketplaces.
FTC vigorously promotes competition in the healthcare industry
through enforcement, study, and advocacy. Competition in healthcare
markets benefits consumers by helping to: (1) Control costs and prices;
(2) improve quality of care; (3) promote innovative products, services,
and delivery models; and (4) expand access to healthcare goods and
services. One of the FTC's long-standing core missions is to ensure
advertising is truthful and not misleading. This allows consumers to
make well-informed decisions about how best to use their resources and
promotes the efficient functioning of market forces by encouraging the
dissemination of accurate information. As addressed below, this
proposed workshop is consistent with these FTC priorities.
As the marketplace of biological products continues to expand and
evolve, FDA and FTC expect an increase in promotional activities
involving reference products and biosimilar and interchangeable
products. FDA, in collaboration with FTC, supports and encourages
competitive markets for biological products. Supporting a competitive
marketplace for biological products including biosimilar and
interchangeable products, is essential for patient access to medicines
and reducing healthcare costs. Biological products play a critical role
in the treatment of many serious illnesses, including rare genetic
disorders, autoimmune diseases, and cancer. For many of these
conditions, there are no treatment alternatives other than biological
products.
Both FDA and FTC have serious concerns about false or misleading
communications regarding reference products and biosimilar or
interchangeable products, and the potential negative effects of such
communications on public health and competition. False or misleading
comparisons of reference products and biosimilar or interchangeable
products may constitute unfair or deceptive practices that undermine
confidence in biosimilar and interchangeable products. Both agencies
want to ensure that healthcare professionals and patients receive
truthful and nonmisleading information about biological products.
This public workshop is a component of FDA's broader effort to
facilitate the growth of a competitive market for biological products.
In July 2018, FDA issued its Biosimilars Action Plan (see https://www.fda.gov/media/114574/download), which focuses on four areas of FDA
activities: (1) Improving the efficiency of the biosimilar and
interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition. This
joint FDA and FTC workshop furthers the activities set forth in the
Biosimilars Action Plan.
II. Topics for Discussion at the Public Workshop
FDA and FTC are holding this public workshop to engage with
stakeholders about certain aspects of a competitive market for
biological products,
[[Page 6205]]
including biosimilars and interchangeable products, and to discuss the
important impact these products have on public health. This includes:
U.S. Biosimilar Markets and FDA Approval Process;
Enforcement Activities by FDA and FTC;
The Benefits of Competition; and
Improving Stakeholder Engagement: Education and Access.
FDA and FTC also encourage comments from stakeholders and the
public relating to steps FDA and FTC can take to facilitate a
competitive market for biological products.
III. Participating in the Public Workshop
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. An agenda for the
workshop and any other background materials will be made available 5
days before the workshop at https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020. If you need special accommodations
because of a disability, please contact Sandra Benton (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the workshop.
Registration and Requests for Open Public Workshop Speaker Slots.
For those interested in participating as an Open Public Workshop
speaker, please register at https://www.eventbrite.com/e/86931096249 as
``In-person Open Public Workshop presenter.'' Open Public Workshop
registrations are due by February 24, 2020; however, if time is
available, you may sign up as an Open Public Workshop speaker the day
of the meeting. Time and space are limited and available on a first-
come, first-served basis. Open Public Workshop speakers may be assigned
no more than 5 minutes for their presentation and will deliver oral
testimony only (no accompanying slide deck).
We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations and request time for a
joint presentation. All requests to make oral presentations must be
received by February 24, 2020. No commercial or promotional material
will be permitted to be presented or distributed at the public
workshop.
In-Person Attendance: For those who would like to attend in person,
but who are not participating in the Open Public Workshop, please
register at https://www.eventbrite.com/e/86931096249 as ``In-person
attendee--no participation.'' You may choose not to register; however,
seating is limited, and space will be available on a first-come, first-
served basis.
Persons attending FDA's workshops are advised that FDA is not
responsible for providing access to electrical outlets.
Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will provide a live webcast of the workshop. To
join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020 for the webcast
address. Please register at https://www.eventbrite.com/e/86931096249 as
``online (webcast only).''
Media: Please register at https://www.eventbrite.com/e/86931096249
as ``Media'' by March 4, 2020.
Transcripts: Please be advised that when a transcript of the public
workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02101 Filed 2-3-20; 8:45 am]
BILLING CODE 4164-01-P
